ENDURANT ABDOMINAL STENT GRAFT SYSTEM

MDR report key: 2893545 · Received January 2, 2013

Report

Report Number: 2953200-2013-00005
Event Type: Injury
Date Received: January 2, 2013
Date of Event: December 5, 2012
Report Date: January 7, 2013
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION RESULTS AND CONCLUSIONS: (ENDOLEAK). (TYPE II ENDOLEAK).

Description of Event or Problem · 1

AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 5.4 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 20 MM IN DIAMETER AND 23 MM IN LENGTH. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT A SMALL ENDOLEAK WAS NOTED ON THE ANGIOGRAM. THE PHYSICIAN COULD NOT DETERMINE IF THIS WAS TYPE II OR TYPE III; THEREFORE, BALLOONING OF THE CONTRALATERAL JUNCTION WAS PERFORMED. IT WAS NOTED THAT THE CONTRALATERAL LIMB WAS DEPLOYED ON THE FLOW DIVIDER MARKER AND OVERLAP WAS CONSIDERED TO BE ADEQUATE. ANGIOGRAPHY SHOWED THE ENDOLEAK WAS STILL PRESENT; HOWEVER, NO FURTHER INTERVENTION WAS PERFORMED. ALTHOUGH A TYPE III ENDOLEAK COULD NOT BE RULED OUT, THE PHYSICIAN BELIEVES THE ENDOLEAK IS LIKELY A TYPE II AND IT IS SMALL ENOUGH THAT IT WOULD RESOLVE ON ITS OWN WITHOUT FURTHER INTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
578	ENDURANT ABDOMINAL STENT GRAFT SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V01135646

Patients

Seq	Age	Sex	Outcome	Treatment
1	00064 YR